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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K031083
Device Name OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact JAMES W HART
Correspondent
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact JAMES W HART
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MBI  
Date Received04/04/2003
Decision Date 06/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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